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| Product NDC Code | 84165-104 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Drug Name | Pain relief gel-patch |
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| Type | Brand | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Dosage Form | PATCH | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| RxCUI drug identifier | 1249758 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Application Number | M017 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Labeler Name | Guangzhou Zhupuyou E-commerce Co., Ltd | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Lidocaine 4% Menthol 1%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Adults and Children above 12 years old: Clean and dry the affected area. Tear off the protective film and apply the exposed part ofthe patch to the the affected area. Carefully remove remaining film while pressing the patchfirmly on the skin. Remove patch from the skin after at most 8-hourapplication. Children under age of 12: Consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Dihydroxyaluminum Aminoacetate Edetate Disodium Glycerin Hydroxyacetophenone Kaolin Mineral Oil Polyacrylic Acid Polysorbate 80 PolyvinylPyrrolidone Propylene Glycol Sodium Polyacrylate Tartaric Acid Titanium Dioxide Water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back,neck, hips, shoulders,elbows.
Purpose
Information about the drug product’s indications for use.Topical Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.PAIN RELIEF Gel-Patch Lidocaine, Menthol TITANIUM DIOXIDE MENTHOL MENTHOL DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS EDETATE DISODIUM PROPYLENE GLYCOL GLYCERIN KAOLIN POVIDONE K90 MINERAL OIL WATER SODIUM POLYACRYLATE (2500000 MW) LIDOCAINE LIDOCAINE HYDROXYACETOPHENONE POLYSORBATE 80 TARTARIC ACID POLYACRYLIC ACID (250000 MW)
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.label label2
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.PAIN RELIEF Gel-Patch
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.on wounds or damaged skin with a heating pad or device with other ointments, creams, sprays, or liniments if you are allergic to any ingredients of this product.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.lf swallowed accidentally, get medical help or contact with Poison Control Center immediately
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.skin reactions such as redness, swelling, blistering or other discomfort occur symptoms persist for more than 7 days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.use only as directed avoid contact with the eyes, mucous membranes, or rashes do not bandage tightly
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.For external use only
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API